Cancer Breakthroughs 2020, also known as Cancer Moonshot 2020 is a coalition with the goal of finding vaccine-based immunotherapies against cancer.
By pooling the resources of multinational pharmaceutical, biotechnology
companies, academic centers and oncologists, it intends to create
access to over 60 novel and approved agents under exploration in the war
against cancer and is expected to enable rapid testing of novel
immunotherapy combination protocols. The initiative is being managed by a
consortium of companies called The National Immunotherapy Coalition.
The difficulty of treating cancer has led researchers to develop
more and more targeted drugs and immune therapies, with the future goal
of hitting "cancers with several such treatments at once, much the way
AIDS was tamed when researchers developed drugs to strike the virus at
its vulnerable points." This new form of combination therapy is needed as cancer is heterogeneous and multiple methods are needed to target multiple types of cancer.
Some cancer specialists have expressed optimism that science has
entered a "new era with the ability to rapidly determine the sequences
of genes in tumor cells, searching for mutations that may be driving the
cancer’s growth." Others call it "unrealistic".
National Immunotherapy Coalition (NIC)
Cancer
Breakthroughs 2020 is led by the National Immunotherapy Coalition
(NIC), an initiative reportedly led by Los Angeles billionaire Patrick Soon-Shiong. Participating members include pharmaceutical companies Amgen and Celgene, biotech companies including NantWorks, NantKwest, Etubics, Altor BioScience, and Precision Biologics, a subsidiary of NantWorks, major academic cancer centers, community oncologists, health insurer Independence Blue Cross, and Bank of America, reportedly one of the largest self-insured companies in the U.S.
Research scope
The scope of the project is to conduct dozens of small-scale clinical trials over the next few years in the field of immunotherapy, with as many as 20,000 patients. These trials are intended to be followed by larger trials. The project's goals will be considered met when long-lasting remission is achieved for cancer patients.
Themes pursued
Cancer Breakthroughs 2020 is pursuing immunotherapy and the following themes:
Validation of Big Science: Complex science involving the
human immune system and the validation of the safety and efficacy of
combination therapy must be tested by reputable scientific enterprises
in an unbiased manner without any prejudices other than the interest of
the patient.
Access to novel agents and approved drugs: One of the major
challenges facing rapid progress in this field is that numerous
pharmaceutical and biotech companies each have their own
immunotherapeutic agents in the form of antibodies, immune cells, and
vaccines in preclinical and clinical studies.
FDA Regulation: Novel approaches for the adaptive combination
of novel agents in this new paradigm where the combined multi-agents
serve as a systems biological approach to the treatment of cancer.
Care coordination and real-time monitoring of safety and outcomes with integration of complex molecular data, phenotypic data obtained from disparate electronic records.
Ability to measure outcomes and cost in real time to enable
payers to pay for value rather than procedures and establish an adaptive
learning system for enhanced predictive modeling.
Network Infrastructure: Highly secure bandwidth to transmit big data and interrogate complex molecular information in a large scale.
QUILT
Cancer
Breakthroughs 2020 incorporates a concept called QUILT, which stands for
QUantitative Integrative Lifelong Trial. QUILT is designed to leverage
patients' immune systems, such as dendritic cell, T cell (lymphocyte) and natural killer cell
(NK cell) therapies, and testing a variety of treatments including
novel combinations of vaccines, cell-based immunotherapy, metronomic
(regularly administered) chemotherapy, low dose radiotherapy and immunomodulators, as well as check point inhibitors, in patients who have undergone next generation whole genome, transcriptome and quantitative proteomic analysis.
Related initiatives
Partnership for Accelerating Cancer Therapies
The
Partnership for Accelerating Cancer Therapies (PACT) was announced in
October 2017 as a collaboration between the National Institutes of
Health and eleven pharmaceutical companies. This agreement provides $215 million in funding over the next five years. This initiative is mainly focused on immunotherapy.
Critics
said that the idea of curing cancer according to a Breakthroughs
analogy was "entirely unrealistic", and cited President Richard Nixon's
"failed" War on Cancer.
Cancer turned out to be not one disease, but hundreds, and the idea of
curing cancer once and for all is "misleading and outdated".
The New York Times reported how Andrew von Eschenbach,
director of the National Cancer Institute, announced in 2003 that his
goal was to “eliminate suffering and death” caused by cancer by 2015.
During an appropriations hearing, Senator Arlen Specter
(R-PA) asked von Eschenbach what it would take to move the date up to
2010. Von Eschenbach said he could do it with a proposed budget of $600
million a year. Specter died of cancer in 2012.
Health oriented news website STAT News
published an editorial criticizing Cancer Breakthroughs as a program
that is designed to support Soon-Shiong's companies while making little
progress to cure cancer. The article stated, "At its core, the
initiative appears to be an elaborate marketing tool for Soon-Shiong — a
way to promote his pricey new cancer diagnostic tool at a time when he
badly needs a business success, as his publicly-traded companies are
losing tens of millions per quarter."
The budget for Cancer Breakthroughs 2020 is undisclosed.
The approval of drugs and devices would be streamlined, according
to supporters, and treatments would reach the market more quickly. The
argument made by opponents was that it would allow the marketing of
riskier or less effective treatments by allowing the approval of drugs
and devices on the basis of flimsier evidence, bypassing randomized,
controlled trials.
The bill incorporated the Helping Families In Mental Health Crisis Act, first introduced by then-Congressman Tim Murphy,
R-Pa., which increased the availability of psychiatric hospital beds
and established a new assistant secretary for mental health and
substance use disorders.
Content
Research and drug development
Division A, titled "21st Century Cures," contains provisions related to National Institutes of Health funding and administration, reducing opioid abuse, medical research, and drug development.
The Comprehensive Addiction and Recovery Act (CARA)
was passed a few months earlier. This act authorized many
harm-reduction strategies, including increased access to the overdose
reversal drug naloxone for the opioid crisis, but didn't provide any federal funding for implementation. The 21st Century Cures Act designated $1 billion in grants for states over two years to fight the opioid epidemic. The money may be used to improve prescription drug monitoring programs,
to make treatment programs more accessible, to train healthcare
professionals in best practices of addiction treatment, and to research
the most effective approaches to prevent dependency.
FDA drug approval process
The 21st Century Cures Act modified the FDA Drug Approval process.
It was intended to expedite the process by which new drugs and devices
are approved by easing the requirements put on drug companies looking
for FDA
approval on new products or new indications on existing drugs. For
instance, under certain conditions, the act allows companies to provide
"data summaries" and "real world evidence" such as observational studies, insurance claims data, patient input, and anecdotal data rather than full clinical trial results.
Targeted drugs for rare diseases
The
21st Century Cures Act facilitates the development and approval of
genetically targeted and variant protein targeted drugs for treatment of
rare diseases.
Informed consent
In section 3024, the 21st Century Cures Act allows researchers to waive the requirement for "informed consent"
in cases where clinical testing of drugs or devices "poses no more than
minimal risk" and "includes appropriate safeguards to protect the
rights, safety, and welfare of the human subject."
One example is a high-tech bandage that monitors blood flow.
Standard procedure requires researchers to obtain the patient's
permission before testing any new device on them. However, in this
example, researchers might want to test the bandage on unconscious
patients. In such circumstances, researchers may waive an informed
consent requirement since the patient is still getting the standard,
medically accepted care of blood pressure and heart rate monitoring.
Researchers would still need to obey standard research protocols
including institutional review boards to approve their research design and ethics.
Human research subject protections
The 21st Century Cures Act calls on the Secretary of Health and Human Services to harmonize differences between the HHS
Human Subject Regulations and FDA Human Subject Regulations. In so
doing, the Secretary may change rules applying to vulnerable populations
in order "to reduce regulatory duplication and unnecessary delays" and
"modernize such provisions in the context of multisite and cooperative
research projects."
Section 3023 provides for joint or shared review of research,
review by institutional review boards other than that of the sponsor of
research, and use of other means "to avoid duplication of effort."
Medical research
The act allocates $4.8 billion to the National Institutes of Health for precision medicine and biomedical research. Of this, $1.5 billion is earmarked for research on brain disease. Another $1.8 billion is dedicated to cancer research in what is called the "Beau Biden Cancer Moonshot" initiative, named in honor of Vice President Joe Biden's son, who died of brain cancer in 2015. In October 2016, the Cohort Program was renamed as the All of Us Research Program.
(This is unrelated to the privately funded Cancer Breakthroughs 2020, also known as "Cancer Moonshot 2020".)
The
act requires sale of 25 million barrels of crude oil (10,000,000 in
2017, 9,000,000 in 2018, and 6,000,000 in 2019) from the Strategic Petroleum Reserve. Revenue from these sales will provide part of the NIH funding provided in the law.
Electronic health records information blocking
The Act defined interoperability and prohibited information blocking. Information blocking is defined as a practice that interferes with or prevents access to electronic health information, that is, information about a patient's medical history or treatment.
Under section 4004, information blocking can expose entities to fines of up to $1 million per violation.
Medical software
Medical software is regulated as a medical device by the FDA in the Federal Food, Drug, and Cosmetic Act.
Section 3060 of the 21st Century Cures Act was created as an amendment
to section 520 of the FD&C Act, which addressed how medical devices
are defined.
It outlined software functions that would be exempt from FDA
regulation, such as those used for administrative purposes, encouraging a
healthy lifestyle, electronic health records, clinical laboratory test results and related information, and clinical decision tools.
Behavioral health
Division
B, titled "Helping Families in Mental Health Crisis," addresses the
prevention and treatment of mental illnesses and substance abuse,
treatment coverage, communication permitted by HIPAA, and interactions with law enforcement and the criminal justice system.
The law strengthens mental health parity regulation, which require insurance
companies to cover mental health treatments to the same extent and in
the same way as medical treatments. It also includes grants to provide
community mental health resources, suicide prevention and intervention programs, and de-escalation training for law enforcement.
It also provides five-year grants for a demonstration program in which
psychiatry residents and other mental health clinicians will practice in
underserved areas.
Provisions for reform of HIPAA, elevating the standing of families in
commitment decisions, and reforms of procedures for challenging release
decisions, were not included in the final bill.
Some of these provisions were originally proposed in earlier bills, including
the Mental Health Reform Act of 2016 (S. 2680);
the Mental Health and Safe Communities Act of 2015 (H.R. 3722, S. 2002);
the Helping Families in Mental Health Crisis Act of 2016 (H.R. 2646);
the Comprehensive Justice and Mental Health Act of 2015 (H.R. 1854, S. 993);
the Mental Health Awareness and Improvement Act of 2015 (H.R. 5327, S. 1893);
the Justice and Mental Health Collaboration Act of 2015 (H.R. 731); and
the Behavioral Health Care Integration Act of 2016 (H.R. 4388).
Healthcare access and quality improvement
Division C, titled "Increasing Choice, Access, and Quality in Health Care for Americans," concerns Medicare programs and federal tax laws related to health plans for small employers.
The Small Business HRA (QSEHRA)
The
21st Century Cures Act also included provisions that created a QSEHRA
(Qualified Small Employer Health Reimbursement Arrangement), a more
efficient way for small businesses and non-profits to offer health
insurance to their employees.
Legislative history
The 21st Century Cures Act was originally introduced as H.R. 6 by Fred Upton (R–MI) on May 19, 2015. It passed the House on July 10, 2015, but did not pass in the Senate.
More than 1,400 registered lobbyists worked on this bill, representing more than 400 different organizations, mostly pharmaceutical companies.
Of 455 organizations registered to lobby on the bill, the top five by number of reports and specific issues according to OpenSecrets were:
The bill passed the House first by a wide margin. Only five senators voted against it: Elizabeth Warren of Massachusetts; Bernie Sanders of Vermont; Ron Wyden and Jeff Merkley, both of Oregon, all Democrats; and Mike Lee, a Republican of Utah. Warren, Sanders, and Merkley, in particular, objected to the pharmaceutical industry's influence on the bill. In early December 2016, the act had support from both houses of congress.
Stakeholders who criticized the passing of the act include the FDA, advocates for strong protections in clinical research, consumer organizations, and advocates of regenerative medicine. The expedited drug approval process has been one topic of concern and debate. The Public Citizen's Health Research Group and the National Center for Health Research campaigned against the Cures Act in fear that it will endanger public health by weakening FDA standards. Senator Elizabeth Warren
said that the bill had been "hijacked" by the pharmaceutical industry.
She said the legislation watered down safety requirements for new drugs
and devices and then, as a trade-off, called for research funding — at
levels that must be appropriated on an annual basis. John LaMattina, former head of Pfizer research and development and current commentator on the pharmaceutical industry, said that full clinical trials
are necessary to prove effectiveness, and suggests some drugs may now
be approved based on early data and only later proved ineffective.
The Public Citizen's Health Research Group says the designation of
"breakthrough" devices is too broad, and could lead to clearance of
devices that aren't ready for the market.
Lupkin points out that the NIH's funding will need to be
appropriated each year through the normal budget process, and therefore
may be reduced from what this bill promised. The NIH funding was actually less than many advocates hoped for, and earlier versions of the bill had promised.
One of the goals of the bill was streamlining approval, but Jerry Avorn
and Aaron Kesselheim pointed out that a third of medicines are approved
from a single clinical trial averaging fewer than 700 patients; ultimately, however, the law did not allow real-world evidence for approving drugs, but rather for label expansions.
Dissection (from Latindissecare "to cut to pieces"; also called anatomization) is the dismembering of the body of a deceased animal or plant to study its anatomical structure. Autopsy is used in pathology and forensic medicine to determine the cause of death in humans. Less extensive dissection of plants and smaller animals preserved in a formaldehyde solution is typically carried out or demonstrated in biology and natural science classes in middle school and high school, while extensive dissections of cadavers of adults and children, both fresh and preserved are carried out by medical students in medical schools as a part of the teaching in subjects such as anatomy, pathology and forensic medicine. Consequently, dissection is typically conducted in a morgue or in an anatomy lab.
Dissection has been used for centuries to explore anatomy. Objections to the use of cadavers have led to the use of alternatives including virtual dissection of computer models.
In the field of surgery, the term "dissection" or "dissecting"
means more specifically to the practice of separating an anatomical
structure (an organ, nerve or blood vessel) from its surrounding connective tissue in order to minimize unwanted damage during a surgical procedure.
Overview
Plant
and animal bodies are dissected to analyze the structure and function
of its components. Dissection is practised by students in courses of biology, botany, zoology, and veterinary science, and sometimes in arts studies. In medical schools, students dissect human cadavers to learn anatomy. Zoötomy is sometimes used to describe "dissection of an animal".
Human dissection
A key principle in the dissection of human cadavers (sometimes called androtomy)
is the prevention of human disease to the dissector. Prevention of
transmission includes the wearing of protective gear, ensuring the
environment is clean, dissection technique and pre-dissection tests to specimens for the presence of HIV and hepatitis viruses.
Specimens are dissected in morgues or anatomy labs. When provided, they
are evaluated for use as a "fresh" or "prepared" specimen.
A "fresh" specimen may be dissected within some days, retaining the
characteristics of a living specimen, for the purposes of training. A
"prepared" specimen may be preserved in solutions such as formalin and
pre-dissected by an experienced anatomist, sometimes with the help of a diener. This preparation is sometimes called prosection.
Dissection tools. Left to right: scalpels with No. 20 and No. 12 blades, two forceps and scissors
Most dissection involves the careful isolation and removal of individual organs, called the Virchow technique.
An alternative more cumbersome technique involves the removal of the
entire organ body, called the Letulle technique. This technique allows a
body to be sent to a funeral director without waiting for the sometimes
time-consuming dissection of individual organs. The Rokitansky method involves an in situ
dissection of the organ block, and the technique of Ghon involves
dissection of three separate blocks of organs - the thorax and cervical
areas, gastrointestinal and abdominal organs, and urogenital organs.
Dissection of individual organs involves accessing the area in which
the organ is situated, and systematically removing the anatomical
connections of that organ to its surroundings. For example, when
removing the heart, connects such as the superior vena cava and inferior vena cava are separated. If pathological connections exist, such as a fibrous pericardium, then this may be deliberately dissected along with the organ.
Autopsy and necropsy
Dissection is used to help to determine the cause of death in autopsy (called necropsy in other animals) and is an intrinsic part of forensic medicine.
History
Galen (129–c.200 AD), Opera omnia, dissection of a pig. Engraving made in Venice, 1565
Classical antiquity
Human dissections were carried out by the Greek physiciansHerophilus of Chalcedon and Erasistratus of Chios in the early part of the third century BC.
During this period, the first exploration into full human anatomy was
performed rather than a base knowledge gained from 'problem-solution'
delving. While there was a deep taboo in Greek culture concerning human dissection, there was at the time a strong push by the Ptolemaic government to build Alexandria into a hub of scientific study. For a time, Roman law forbade dissection and autopsy of the human body, so anatomists relied on the cadavers of animals or made observations of human anatomy from injuries of the living. Galen, for example, dissected the Barbary macaque
and other primates, assuming their anatomy was basically the same as
that of humans, and supplemented these observations with knowledge of
human anatomy which he acquired while tending to wounded gladiators.
Celsus wrote in On Medicine I Proem 23,
"Herophilus and Erasistratus proceeded in by far the best way: they cut
open living men - criminals they obtained out of prison from the kings
and they observed, while their subjects still breathed, parts that
nature had previously hidden, their position, color, shape, size,
arrangement, hardness, softness, smoothness, points of contact, and
finally the processes and recesses of each and whether any part is
inserted into another or receives the part of another into itself."
Galen was another such writer who was familiar with the studies of Herophilus and Erasistratus.
India
The Ayurvedic Man., c. 18th century
The ancient societies that were rooted in India left behind artwork on how to kill animals during a hunt.
The images showing how to kill most effectively depending on the game
being hunted relay an intimate knowledge of both external and internal
anatomy as well as the relative importance of organs.
The knowledge was mostly gained through hunters preparing the recently
captured prey. Once the roaming lifestyle was no longer necessary it was
replaced in part by the civilization that formed in the Indus Valley.
Unfortunately, there is little that remains from this time to indicate
whether or not dissection occurred, the civilization was lost to the Aryan people migrating.
Early in the history of India (2nd to 3rd century), the Arthashastra described the 4 ways that death can occur and their symptoms: drowning, hanging, strangling, or asphyxiation. According to that source, an autopsy should be performed in any case of untimely demise.
The practice of dissection flourished during the 7th and 8th
century. It was under their rule that medical education was
standardized. This created a need to better understand human anatomy, so
as to have educated surgeons. Dissection was limited by the religious
taboo on cutting the human body. This changed the approach taken to
accomplish the goal. The process involved the loosening of the tissues
in streams of water before the outer layers were sloughed off with soft
implements to reach the musculature. To perfect the technique of
slicing, the prospective students used gourds and squash. These
techniques of dissection gave rise to an advanced understanding of the
anatomy and the enabled them to complete procedures used today, such as
rhinoplasty.
During medieval times the anatomical teachings from India spread
throughout the known world; however, the practice of dissection was
stunted by Islam.
The practice of dissection at a university level was not seen again
until 1827, when it was performed by the student Pandit Madhusudan
Gupta.
Through the 1900s, the university teachers had to continually push
against the social taboos of dissection, until around 1850 when the
universities decided that it was more cost effective to train Indian
doctors than bring them in from Britain. Indian medical schools were, however, training female doctors well before those in England.
The current state of dissection in India is deteriorating. The
number of hours spent in dissection labs during medical school has
decreased substantially over the last twenty years. The future of anatomy education will probably be an elegant mix of traditional methods and integrative computer learning.
The use of dissection in early stages of medical training has been
shown more effective in the retention of the intended information than
their simulated counterparts. However, there is use for the computer-generated experience as review in the later stages.
The combination of these methods is intended to strengthen the
students' understanding and confidence of anatomy, a subject that is
infamously difficult to master.
There is a growing need for anatomist—seeing as most anatomy labs are
taught by graduates hoping to complete degrees in anatomy—to continue
the long tradition of anatomy education.
Islamic world
Page from a 1531 Latin translation by Peter Argellata of Al-Zahrawi's c. 1000 treatise on surgical and medical instruments
From the beginning of the Islamic faith in 610 A.D., Shari'ah law has applied to a greater or lesser extent within Muslim countries, supported by Islamic scholars such as Al-Ghazali. Islamic physicians such as Ibn Zuhr (Avenzoar) (1091–1161) in Al-Andalus, Saladin's physician Ibn Jumay during the 12th century, Abd el-Latif in Egypt c. 1200, and Ibn al-Nafis in Syria and Egypt in the 13th century may have practiced dissection,
but it remains ambiguous whether or not human dissection was practiced.
Ibn al-Nafis, a physician and Muslim jurist, suggested that the
"precepts of Islamic law have discouraged us from the practice of
dissection, along with whatever compassion is in our temperament",
indicating that while there was no law against it, it was nevertheless
uncommon. Islam dictates that the body be buried as soon as possible,
barring religious holidays, and that there be no other means of disposal
such as cremation. Prior to the 10th century, dissection was not performed on human cadavers. The book Al-Tasrif, written by Al-Zahrawi in 1000 A.D., details surgical procedure that differed from the previous standards. The book was an educational text of medicine and surgery which included detailed illustrations. It was later translated and took the place of Avicenna's The Canon of Medicine as the primary teaching tool in Europe from the 12th century to the 17th century.
There were some that were willing to dissect humans up to the 12th
century, for the sake of learning, after which it was forbidden. This
attitude remained constant until 1952, when the Islamic School of
Jurisprudence in Egypt ruled that "necessity permits the forbidden". This decision allowed for the investigation of questionable deaths by autopsy. In 1982, the decision was made by a fatwa that if it serves justice, autopsy is worth the disadvantages.
Though Islam now approves of autopsy, the Islamic public still
disapproves. Autopsy is prevalent in most Muslim countries for medical
and judicial purposes. In Egypt it holds an important place within the judicial structure, and is taught at all the country's medical universities.
In Saudi Arabia, whose law is completely dictated by Shari'ah, autopsy
is viewed poorly by the population but can be compelled in criminal
cases; human dissection is sometimes found at university level. Autopsy is performed for judicial purposes in Qatar and Tunisia. Human dissection is present in the modern day Islamic world, but is rarely published on due to the religious and social stigma.
Tibetan medicine developed a rather sophisticated knowledge of anatomy, acquired from long-standing experience with human dissection. Tibetans had adopted the practice of sky burial because of the country's hard ground, frozen for most of the year, and the lack of wood for cremation. A sky burial begins with a ritual dissection of the deceased, and is followed by the feeding of the parts to vultures on the hill tops. Over time, Tibetan anatomical knowledge found its way into Ayurveda and to a lesser extent into Chinese medicine.
Throughout the history of Christian Europe, the dissection of human
cadavers for medical education has experienced various cycles of
legalization and proscription in different countries. Dissection was
rare during the Middle Ages, but it was practised, with evidence from at least as early as the 13th century.
The practice of autopsy in Medieval Western Europe is "very poorly
known" as few surgical texts or conserved human dissections have
survived.
A modern Jesuit scholar has claimed that the Christian theology
contributed significantly to the revival of human dissection and autopsy
by providing a new socio-religious and cultural context in which the
human cadaver was no longer seen as sacrosanct.
An edict of the 1163 Council of Tours, and an early 14th-century decree of Pope Boniface VIII
have mistakenly been identified as prohibiting dissection and autopsy,
misunderstanding or extrapolation from these edicts may have contributed
to reluctance to perform such procedures. The Middle Ages witnessed the revival of an interest in medical studies, including human dissection and autopsy.
Frederick II (1194–1250), the Holy Roman emperor, ruled that any that
were studying to be a physician or a surgeon must attend a human dissection, which would be held no less than every five years.
Some European countries began legalizing the dissection of executed
criminals for educational purposes in the late 13th and early 14th
centuries. Mondino de Luzzi carried out the first recorded public dissection around 1315.
At this time, autopsies were carried out by a team consisting of a
Lector, who lectured, the Sector, who did the dissection, and the
Ostensor who pointed to features of interest.
The Italian Galeazzo di Santa Sofia made the first public dissection north of the Alps in Vienna in 1404.
Vesalius
in the 16th century carried out numerous dissections in his extensive
anatomical investigations. He was attacked frequently for his
disagreement with Galen's opinions on human anatomy. Vesalius was the
first to lecture and dissect the cadaver simultaneously.
The Catholic Church is known to have ordered an autopsy on
conjoined twins Joana and Melchiora Ballestero in Hispaniola in 1533 to
determine whether they shared a soul. They found that there were two
distinct hearts, and hence two souls, based on the ancient Greek
philosopher Empedocles, who believed the soul resided in the heart.
Human dissection was also practised by Renaissance artists. Though most chose to focus on the external surfaces of the body, some like Michelangelo Buonarotti, Antonio del Pollaiuolo, Baccio Bandinelli, and Leonardo da Vinci
sought a deeper understanding. However, there were no provisions for
artists to obtain cadavers, so they had to resort to unauthorised means,
as indeed anatomists sometimes did, such as grave robbing, body
snatching, and murder.
Anatomization was sometimes ordered as a form of punishment, as,
for example, in 1806 to James Halligan and Dominic Daley after their
public hanging in Northampton, Massachusetts.
In modern Europe, dissection is routinely practised in biological
research and education, in medical schools, and to determine the cause
of death in autopsy. It is generally considered a necessary part of
learning and is thus accepted culturally. It sometimes attracts
controversy, as when Odense Zoo decided to dissect lion cadavers in
public before a "self-selected audience".
In Britain, dissection remained entirely prohibited from the end of
the Roman conquest and through the Middle Ages to the 16th century, when
a series of royal edicts gave specific groups of physicians and
surgeons some limited rights to dissect cadavers. The permission was
quite limited: by the mid-18th century, the Royal College of Physicians and Company of Barber-Surgeons
were the only two groups permitted to carry out dissections, and had an
annual quota of ten cadavers between them. As a result of pressure from
anatomists, especially in the rapidly growing medical schools, the Murder Act 1752 allowed the bodies of executed murderers to be dissected for anatomical research and education. By the 19th century
this supply of cadavers proved insufficient, as the public medical
schools were growing, and the private medical schools lacked legal
access to cadavers. A thriving black market arose in cadavers and body
parts, leading to the creation of the profession of body snatching, and the infamous Burke and Hare murders
in 1828, when 16 people were murdered for their cadavers, to be sold to
anatomists. The resulting public outcry led to the passage of the Anatomy Act 1832, which increased the legal supply of cadavers for dissection.
By the 21st century, the availability of interactive computer
programs and changing public sentiment led to renewed debate on the use
of cadavers in medical education. The Peninsula College of Medicine and Dentistry in the UK, founded in 2000, became the first modern medical school to carry out its anatomy education without dissection.
United States
A teenage school pupil dissecting an eye
In the United States, dissection of frogs became common in college
biology classes from the 1920s, and were gradually introduced at earlier
stages of education. By 1988, some 75 to 80 percent of American high
school biology students were participating in a frog dissection, with a trend towards introduction in elementary schools. The frogs are most commonly from the genus Rana. Other popular animals for high-school dissection at the time of that survey were, among vertebrates, fetal pigs, perch, and cats; and among invertebrates, earthworms, grasshoppers, crayfish, and starfish.
About six million animals are dissected each year in United States high
schools (2016), not counting medical training and research. Most of
these are purchased already dead from slaughterhouses and farms.
Dissection in U.S. high schools became prominent in 1987, when a
California student, Jenifer Graham, sued to require her school to let
her complete an alternative project. The court ruled that mandatory
dissections were permissible, but that Graham could ask to dissect a
frog that had died of natural causes rather than one that was killed for
the purposes of dissection; the practical impossibility of procuring a
frog that had died of natural causes in effect let Graham opt out of the
required dissection. The suit gave publicity to anti-dissection
advocates. Graham appeared in a 1987 Apple Computer commercial for the virtual-dissection software Operation Frog.
The state of California passed a Student's Rights Bill in 1988
requiring that objecting students be allowed to complete alternative
projects. Opting out of dissection increased through the 1990s.
In the United States, 17 states along with Washington, D.C. have enacted dissection-choice laws or policies that allow students in primary and secondary education
to opt out of dissection. Other states including Arizona, Hawaii,
Minnesota, Texas, and Utah have more general policies on opting out on
moral, religious, or ethical grounds. To overcome these concerns, J. W. Mitchell High School in New Port Richey, Florida,
in 2019 became the first US high school to use synthetic frogs for
dissection in its science classes, instead of preserved real frogs.
As for the dissection of cadavers in undergraduate and medical
school, traditional dissection is supported by professors and students,
with some opposition, limiting the availability of dissection.
Upper-level students who have experienced this method along with their
professors agree that "Studying human anatomy with colorful charts is
one thing. Using a scalpel and an actual, recently-living person is an
entirely different matter."
Acquisition of cadavers
The way in which cadaveric specimens are obtained differs greatly according to country.
In the UK, donation of a cadaver is wholly voluntary. Involuntary
donation plays a role in about 20 percent of specimens in the US and
almost all specimens donated in some countries such as South Africa and
Zimbabwe.
Countries that practice involuntary donation may make available the
bodies of dead criminals or unclaimed or unidentified bodies for the
purposes of dissection. Such practices may lead to a greater proportion of the poor, homeless and social outcasts being involuntarily donated.
Cadavers donated in one jurisdiction may also be used for the purposes
of dissection in another, whether across states in the US, or imported from other countries, such as with Libya.
As an example of how a cadaver is donated voluntarily, a funeral home
in conjunction with a voluntary donation program identifies a body who
is part of the program. After broaching the subject with relatives in a
diplomatic fashion, the body is then transported to a registered
facility. The body is tested for the presence of HIV and hepatitis
viruses. It is then evaluated for use as a "fresh" or "prepared"
specimen.
Disposal of specimens
Cadaveric specimens for dissection are, in general, disposed of by cremation.
The deceased may then be interred at a local cemetery. If the family
wishes, the ashes of the deceased are then returned to the family.
Many institutes have local policies to engage, support and celebrate
the donors. This may include the setting up of local monuments at the
cemetery.
Human cadavers are often used in medicine to teach anatomy or surgical instruction.
Cadavers are selected according to their anatomy and availability. They
may be used as part of dissection courses involving a "fresh" specimen
so as to be as realistic as possible—for example, when training
surgeons.
Cadavers may also be pre-dissected by trained instructors. This form of
dissection involves the preparation and preservation of specimens for a
longer time period and is generally used for the teaching of anatomy.
Alternatives
Some
alternatives to dissection may present educational advantages over the
use of animal cadavers, while eliminating perceived ethical issues.
These alternatives include computer programs, lectures, three
dimensional models, films, and other forms of technology. Concern for
animal welfare is often at the root of objections to animal dissection.
Studies show that some students reluctantly participate in animal
dissection out of fear of real or perceived punishment or ostracism from
their teachers and peers, and many do not speak up about their ethical
objections.
One alternative to the use of cadavers is computer technology. At Stanford Medical School, software combines X-ray, ultrasound and MRI imaging for display on a screen as large as a body on a table.
In a variant of this, a "virtual anatomy" approach being developed at
New York University, students wear three dimensional glasses and can use
a pointing device to "[swoop] through the virtual body, its sections as
brightly colored as living tissue." This method is claimed to be "as
dynamic as Imax [cinema]".
Advantages and disadvantages
Proponents
of animal-free teaching methodologies argue that alternatives to animal
dissection can benefit educators by increasing teaching efficiency and
lowering instruction costs while affording teachers an enhanced
potential for the customization and repeat-ability of teaching
exercises. Those in favor of dissection alternatives point to studies
which have shown that computer-based teaching methods "saved academic
and nonacademic staff time … were considered to be less expensive and an
effective and enjoyable mode of student learning [and] … contributed to
a significant reduction in animal use" because there is no set-up or
clean-up time, no obligatory safety lessons, and no monitoring of
misbehavior with animal cadavers, scissors, and scalpels.
With software and other non-animal methods, there is also no
expensive disposal of equipment or hazardous material removal. Some
programs also allow educators to customize lessons and include built-in
test and quiz modules that can track student performance. Furthermore,
animals (whether dead or alive) can be used only once, while non-animal
resources can be used for many years—an added benefit that could result
in significant cost savings for teachers, school districts, and state
educational systems.
Several peer-reviewed comparative studies examining information
retention and performance of students who dissected animals and those
who used an alternative instruction method have concluded that the
educational outcomes of students who are taught basic and advanced
biomedical concepts and skills using non-animal methods are equivalent
or superior to those of their peers who use animal-based laboratories
such as animal dissection.
Some reports state that students' confidence, satisfaction, and
ability to retrieve and communicate information was much higher for
those who participated in alternative activities compared to dissection.
Three separate studies at universities across the United States found
that students who modeled body systems out of clay were significantly
better at identifying the constituent parts of human anatomy than their
classmates who performed animal dissection.
Another study found that students preferred using clay modeling
over animal dissection and performed just as well as their cohorts who
dissected animals.
In 2008, the National Association of Biology Teachers (NABT)
affirmed its support for classroom animal dissection stating that they
"Encourage the presence of live animals in the classroom with
appropriate consideration to the age and maturity level of the students
…NABT urges teachers to be aware that alternatives to dissection have
their limitations. NABT supports the use of these materials as adjuncts
to the educational process but not as exclusive replacements for the use
of actual organisms."
The National Science Teachers Association (NSTA) "supports
including live animals as part of instruction in the K-12 science
classroom because observing and working with animals firsthand can spark
students' interest in science as well as a general respect for life
while reinforcing key concepts" of biological sciences. NSTA also
supports offering dissection alternatives to students who object to the
practice.
The NORINA database lists over 3,000 products which may be used
as alternatives or supplements to animal use in education and training. These include alternatives to dissection in schools. InterNICHE has a similar database and a loans system.
Mice are the most commonly used mammal species for live animal research. Such research is sometimes described as vivisection.
Vivisection (from Latin vivus 'alive', and sectio 'cutting') is surgery conducted for experimental purposes on a living organism, typically animals with a central nervous system, to view living internal structure. The word is, more broadly, used as a pejorative catch-all term for experimentation on live animals by organizations opposed to animal experimentation, but the term is rarely used by practising scientists. Human vivisection, such as live organ harvesting, has been perpetrated as a form of torture.
Animal vivisection
An anesthetized pig used for training a surgeon
Research requiring vivisection techniques that cannot be met through other means is often subject to an external ethics review in conception and implementation, and in many jurisdictions use of anesthesia is legally mandated for any surgery likely to cause pain to any vertebrate.
In the United States, the Animal Welfare Act
explicitly requires that any procedure that may cause pain use
"tranquilizers, analgesics, and anesthetics" with exceptions when
"scientifically necessary". The act does not define "scientific necessity" or regulate specific scientific procedures, but approval or rejection of individual techniques in each federally funded lab is determined on a case-by-case basis by the Institutional Animal Care and Use Committee,
which contains at least one veterinarian, one scientist, one
non-scientist, and one other individual from outside the university.
In the United Kingdom, any experiment involving vivisection must be licensed by the Home Secretary. The Animals (Scientific Procedures) Act 1986
"expressly directs that, in determining whether to grant a licence for
an experimental project, 'the Secretary of State shall weigh the likely
adverse effects on the animals concerned against the benefit likely to
accrue.'"
In Australia,
the Code of Practice "requires that all experiments must be approved by
an Animal Experimentation Ethics Committee" that includes a "person
with an interest in animal welfare who is not employed by the
institution conducting the experiment, and an additional independent
person not involved in animal experimentation."
Anti-vivisectionists have played roles in the emergence of the animal welfare and animal rights movements, arguing that animals and humans have the same natural rights
as living creatures, and that it is inherently immoral to inflict pain
or injury on another living creature, regardless of the purpose or
potential benefit to mankind.
Vivisection and anti-vivisection in the 19th century
At
the turn of the 19th century, medicine was undergoing a transformation.
The emergence of hospitals and the development of more advanced medical
tools such as the stethoscope are but a few of the changes in the
medical field.
There was also an increased recognition that medical practices needed
to be improved, as many of the current therapeutics were based on
unproven, traditional theories that may or may not have helped the
patient recover. The demand for more effective treatment shifted
emphasis to research with the goal of understanding disease mechanisms
and anatomy.
This shift had a few effects, one of which was the rise in patient
experimentation, leading to some moral questions about what was
acceptable in clinical trials and what was not. An easy solution to the
moral problem was to use animals in vivisection experiments, so as not
to endanger human patients. This, however, had its own set of moral
obstacles, leading to the anti-vivisection movement.
François Magendie (1783–1855)
Pro-vivisection cartoon in 1911
One polarizing figure in the anti-vivisection movement was François Magendie. Magendie was a physiologist at the Académie Royale de Médecine in France, established in the first half of the 19th century.
Magendie made several groundbreaking medical discoveries, but was far
more aggressive than some of his other contemporaries with his use of
animal experimentation. For example, the discovery of the different
functionalities of dorsal and ventral spinal nerve roots was achieved by
both Magendie, as well as a Scottish anatomist named Charles Bell. Bell
used an unconscious rabbit because of "the protracted cruelty of the
dissection", which caused him to miss that the dorsal roots were also
responsible for sensory information. Magendie, on the other hand, used
conscious, six-week-old puppies for his own experiments.
While Magendie's approach was more of an infringement on what would
today be referred to as animal rights, both Bell and Magendie used the
same rationalization for vivisection: the cost of animal lives and
experimentation was well worth it for the benefit of humanity.
Many viewed Magendie's work as cruel and unnecessarily torturous.
One note is that Magendie carried out many of his experiments before
the advent of anesthesia, but even after ether was discovered it was not
used in any of his experiments or classes.
Even during the period before anesthesia, other physiologists
expressed their disgust with how he conducted his work. One such
visiting American physiologist describes the animals as "victims" and
the apparent sadism that Magendie displayed when teaching his classes.
The cruelty in such experiments actually even led to Magendie's role as
an important figure in animal-rights legislation, such as his
experiments being cited in the drafting of the British Cruelty to
Animals Act 1876 and Cruel Treatment of Cattle Act 1822, otherwise known as Martin's Act, with its namesake, Irish MP and well known anti-cruelty campaigner Richard Martin
describing Magendle as "disgrace to Society" after one of Magendle's
public vivisections, described by Martin as "anatomical theatres", which
was widely commented on at the time reportedly involving a greyhound's
dissection potentially over two days. Magendle faced widespread opposition in British society, among the general public but also his contemporaries, including William Sharpey
who described his experiments aside from cruel as "purposeless" and
"without sufficient object", a feeling he claimed was shared among other
physiologists.
The Cruelty to Animals Act, 1876
in Britain determined that one could only conduct vivisection on
animals with the appropriate license from the state, and that the work
the physiologist was doing had to be original and absolutely necessary. The stage was set for such legislation by physiologist David Ferrier.
Ferrier was a pioneer in understanding the brain and used animals to
show that certain locales of the brain corresponded to bodily movement
elsewhere in the body in 1873. He put these animals to sleep, and caused
them to move unconsciously with a probe. Ferrier was successful, but
many decried his use of animals in his experiments. Some of these
arguments came from a religious standpoint. Some were concerned that
Ferrier's experiments would separate God from the mind of man in the
name of science.
Some of the anti-vivisection movement in England had its roots in
Evangelicalism and Quakerism. These religions already had a distrust for
science, only intensified by the recent publishing of Darwin's Theory
of Evolution in 1859.
Neither side was pleased with how the Cruelty to Animals Act 1876
was passed. The scientific community felt as though the government was
restricting their ability to compete with the quickly advancing France
and Germany with new regulations. The anti-vivisection movement was also
unhappy, but because they believed that it was a concession to
scientists for allowing vivisection to continue at all.
Ferrier would continue to vex the anti-vivisection movement in Britain
with his experiments when he had a debate with his German opponent,
Friedrich Goltz. They would effectively enter the vivisection arena,
with Ferrier presenting a monkey, and Goltz presenting a dog, both of
which had already been operated on. Ferrier won the debate, but did not
have a license, leading the anti-vivisection movement to sue him in
1881. Ferrier was not found guilty, as his assistant was the one
operating, and his assistant did have a license.
Ferrier and his practices gained public support, leaving the
anti-vivisection movement scrambling. They made the moral argument that
given recent developments, scientists would venture into more extreme
practices to operating on "the cripple, the mute, the idiot, the
convict, the pauper, to enhance the 'interest' of [the physiologist's]
experiments".
Human vivisection
It is possible that human vivisection was practised by some Greek anatomists in Alexandria in the 3rd century BCE. Celsus in De Medicina states that Herophilos of Alexandria vivisected some criminals sent by the king. The early Christian writer Tertullian
states that Herophilos vivisected at least 600 live prisoners, although
the accuracy of this claim is disputed by many historians.
In the 12th century CE, Andalusian Arab Ibn Tufail elaborated on human vivisection in his treatise called Hayy ibn Yaqzan. In an extensive article on the subject, Iranian academic Nadia Maftouni believes him to be among the early supporters of autopsy and vivisection.
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